Moms@Home for Pregnancy-induced Hypertension

(Moms@Home Trial)

Overseen By Abigail Arthur, MBChB, MPH

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: University of Massachusetts, Worcester

Disqualifiers: Severe hypertension, Preeclampsia, Substance use, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

Duration: 8 weeks

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new digital health method called Moms@Home, designed to help pregnant women with high blood pressure monitor their health at home. Participants will use either a smartphone app with devices like a digital blood pressure monitor and a FitBit or a paper diary for tracking. It suits pregnant women comfortable with smartphones who have been diagnosed with high blood pressure between 8 and 26 weeks of pregnancy. As an unphased trial, this study allows participants to contribute to innovative research that could enhance health tracking for pregnant women with hypertension.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your healthcare provider.

What prior data suggests that the Moms@Home digital health approach is safe for pregnant women with hypertension?

Research has shown that the Moms@Home digital health app is being tested for its safety and effectiveness in helping pregnant women manage high blood pressure at home. This app allows users to track their blood pressure and physical activity using a digital monitor and a fitness tracker.

While specific data on the safety of Moms@Home is not yet available, similar apps are generally well-tolerated because they focus on self-monitoring rather than medication. Studies of similar apps have reported no negative effects. As a digital tool, Moms@Home is less likely to cause side effects compared to new medicines still under testing.

Overall, based on knowledge of similar digital health tools, using the app to manage blood pressure at home is considered safe. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Moms@Home for pregnancy-induced hypertension because it leverages digital technology to enhance self-monitoring and patient engagement. Unlike traditional methods that rely on paper diaries and in-person visits, Moms@Home uses a smartphone app combined with a digital blood pressure monitor and a FitBit tracker. This setup allows for real-time data collection and feedback, potentially leading to more personalized and timely intervention. The convenience and immediacy of this digital approach could transform how pregnant individuals manage hypertension, making it easier and more effective compared to standard care practices.

What evidence suggests that the Moms@Home approach is effective for managing pregnancy-induced hypertension?

Research has shown that checking blood pressure at home can help manage high blood pressure during pregnancy. In this trial, participants in the Moms@Home arm will use a digital app to track their blood pressure and physical activity. Early results suggest that mobile health tools like this can improve blood pressure management. The app also uses storytelling to engage users and encourage regular monitoring. While specific data on Moms@Home is still being gathered, digital health tools appear promising for pregnant women needing to manage high blood pressure effectively. ^{1 2 3 4 6}

Who Is on the Research Team?

Lara Kovell, MD,MSc

Principal Investigator

University of Massachusetts Medical School, Worcester

Are You a Good Fit for This Trial?

This trial is for pregnant women aged 18-50 with gestational (20-26 weeks) or chronic hypertension (8-26 weeks), receiving care at UMass Memorial Health in Worcester, MA. Participants must be willing to share blood pressure data and comfortable using smartphones and mobile apps. Both English and Spanish speakers can join.

Inclusion Criteria

I am currently pregnant.

I am a patient at the UMass Memorial Health Obstetrics clinics in Worcester.

I am willing to share my blood pressure data from home.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use the Moms@Home app and digital BP monitor for home blood pressure monitoring and physical activity tracking

8 weeks

Baseline, 4 weeks, 8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Focus group interviews

Qualitative focus groups to assess ease of use, barriers, and facilitators related to the intervention and long-term maintenance

At least 3 months after randomization

What Are the Treatments Tested in This Trial?

Interventions

• Moms@Home

Trial Overview The Moms@Home pilot study is testing a mobile health intervention designed to improve home blood pressure monitoring among diverse pregnant women with hypertension, comparing it against an enhanced standard of care.

How Is the Trial Designed?

Group I: Moms@Home arm Experimental Treatment 1 Intervention

Participants randomized to Moms@Home will receive the Moms@Home app (± Samsung smartphone) to self-report data including home blood pressure monitoring values from a digital blood pressure monitor and physical activity data from a FitBit activity tracker.

Group II: Enhanced Standard Care arm Active Control 1 Intervention

Participants randomized to Enhanced Standard Care (ESC) will receive a paper diary to self-report data including measurements from a digital blood pressure monitor.

Who Is Running the Clinical Trial?

University of Massachusetts, Worcester

Lead Sponsor

Trials

372

Recruited

998,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06835959

Moms@Home: A Storytelling-based Mobile Health ... The study aims to standardize and test a storytelling approach to promote HBPM and improve BP management and pregnancy-specific outcomes in pregnant women ...

2. trialx.com trialx.com/clinical-trials/listings/318892/momshome-a-storytelling-based-mobile-health-intervention-to-improve-blood-pressure-management-in-pregnancy/

Moms@Home: A Storytelling-based Mobile Health ... The study aims to standardize and test a storytelling approach to promote HBPM and improve BP management and pregnancy-specific outcomes in pregnant women with ...

3. withpower.com withpower.com/trial/phase-chronic-hypertension-2-2025-27ac2

Moms@Home for Pregnancy-induced Hypertension This pilot study will examine the effects of a digital health approach, Moms@Home, on home blood pressure monitoring in a diverse population of pregnant women ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12296244/

A Digital Lifestyle App for Hypertension During Pregnancy Chronic hypertension affects 1%‐5% of pregnancies, increasing women's risks of adverse pregnancy outcomes and life-long cardiovascular disease ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2210778925000133

Home blood pressure monitoring and mobile health ... A cross-sectional survey was conducted on HBPM practices/training and interest in using mobile health (mHealth) applications among pregnant persons.

6. mprnews.org mprnews.org/story/2024/12/20/home-monitoring-helps-moms-track-blood-pressure-after-birth-reducing-risks

Home monitoring helps moms track blood pressure after ... New mothers diagnosed with high blood pressure disorders in pregnancy receive equipment to monitor and report their blood pressure from home for ...